Tracheal StenosisNCT07463742
Transcriptomic Profile Changes in Benign Tracheal Stenosis: Wedge Resection vs. Radial Incision
A study testing Bronchoscopy, carbon dioxide (CO2) laser wedge resection and Radial incision with dilation in people with Tracheal Stenosis, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Some people develop a narrowing of their windpipe (trachea), called benign tracheal stenosis, which can make it hard to breathe. Doctors often treat this by using a bronchoscope-a thin, flexible tube with a camera-to open up the airway or remove scar tissue. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tracheal Stenosis
- What is being tested?
- Bronchoscopy, carbon dioxide (CO2) laser wedge resection and Radial incision with dilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 May 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic tracheal stenosis
- idiopathic subglottic stenosis
- iatrogenic tracheal stenosis from intubation or tracheostomy
Who cannot join
- positive ANA or ANCA
- tracheal stenosis from infection, i.e. TB
- tracheal stenosis with cartilage fracture
- tracheal stenosis with malacia
- tracheal stenosis from malignancy
- tracheal stenosis from benign tumor
- presence of glottic or supraglottic stenosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland
Baltimore, Maryland, 21021
Chenchen Zhang, MD, 410-328-8138, chenchen.zhang@som.umaryland.edu
About this study
Official title: A Randomized Controlled Trial Comparing Transcriptomic Profile Changes Following Carbon Dioxide (CO2) Laser Wedge Resection Versus Radial Incision for Benign Tracheal Stenosis
Some people develop a narrowing of their windpipe (trachea), called benign tracheal stenosis, which can make it hard to breathe. Doctors often treat this by using a bronchoscope-a thin, flexible tube with a camera-to open up the airway or remove scar tissue. While these procedures help patients breathe better, we do not fully understand why the narrowing occurs or how the tissue heals afterward.
The purpose of this study is to better understand the biological changes in the airway tissue before and after these standard medical procedures. During the procedure, small samples of tissue that would already be collected as part of normal care will be analyzed in the laboratory. The results may help doctors learn more about airway healing and could guide better treatments in the future.
Read the detailed description
Benign tracheal stenosis (BTS) is an uncommon but potentially life-threatening condition caused by fibroinflammatory scarring that narrows the airway. Etiologies include post-intubation, tracheostomy, and idiopathic disease. Bronchoscopic intervention is the first-line treatment; however, recurrence rates exceed 50%, and the optimal technique remains uncertain. Two widely used modalities-carbon dioxide (CO₂) laser wedge resection and radial incision with dilation-have never been directly compared in a randomized trial. Preliminary evidence, including our meta-analysis, suggests wedge resection may yield lower recurrence rates and longer recurrence-free intervals, but the biological mechanisms underlying these differences remain unknown.
This project will conduct a randomized pilot study of 40 BTS patients comparing CO₂ laser wedge resection and radial incision with dilation. Endobronchial biopsies will be collected before and one month after intervention and analyzed using bulk ribonucleic acid (RNA) sequencing and spatial transcriptomics to capture both global and spatially resolved gene expression changes. This dual-modality approach will map molecular pathways involved in fibrosis resolution, immune cell dynamics, and epithelial repair. Patients will be followed for two years with standardized clinical, physiologic, and imaging assessments, and molecular signatures will be correlated with recurrence-free survival and other clinically meaningful outcomes.
By combining prospective clinical data with high-resolution transcriptomic profiling, this study addresses critical gaps in mechanistic understanding and comparative effectiveness evidence for BTS management. The findings will establish a biologic framework for selecting optimal bronchoscopic approaches, identify candidate therapeutic targets to prevent recurrence, and generate effect-size estimates to power a future multicenter randomized controlled trial.
- Conditions
- Tracheal Stenosis
- Being tested
- Bronchoscopy, carbon dioxide (CO2) laser wedge resection, Radial incision with dilation
- Keywords
- tracheal stenosis, bronchoscopy, wedge resection, CO2 laser
- Medical subject headings
- Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy, carbon dioxide (CO2) laser wedge resectionProcedure or surgery
CO2 laser wedge resection - removing scar tissue with laser, leading tissue bridges.
Radial incision with dilationProcedure or surgery
Radial incision with dilation - making radial cuts at the circumferential scar site, followed by balloon dilation.
| Study group | Role | What they receive |
|---|---|---|
| Carbon dioxide (CO2) laser wedge resection | Experimental | Not described Receives: Procedure: Bronchoscopy, carbon dioxide (CO2) laser wedge resection |
| Radial incision and dilation | Active comparator | Not described Receives: Procedure: Radial incision with dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in transcriptomic pathway activation scores
Measured: at the time of the second procedure (1 month from the initial invervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 May 2026
- Primary completion1 May 2031 (estimated)
- Study completion1 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tracheal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1\. Carbon dioxide (CO2) laser wedge resection; 2. Radial incision and dilation
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chenchen Zhang, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463742
- Sponsor's protocol ID
- HP-00112650
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) from this study will be shared in a de-identified form for research purposes only, consistent with participant confidentiality protections. The shared dataset will include: Clinical data: age, sex, relevant medical history related to benign tracheal stenosis, treatment type (CO₂ laser wedge resection vs. radial incision with dilation), recurrence status, symptom scores, spirometry results (PIF, PEF), and imaging findings. Transcriptomic data: bulk RNA-seq and spatial RNA-seq gene expression data from pre- and post-treatment tissue samples, without any personally identifiable information. Exclusions: No names, initials, dates of birth, social security numbers, or other direct identifiers will be shared. All samples and data will be linked only by unique study codes. Intended Use: Shared data will be available to qualified researchers for secondary analyses of benign tracheal stenosis or related molecular research, in accordance with institutional an
Publications
Kang N, Ho A, Bain PA, Zhang C. Comparing CO2 Laser Wedge Resection to Radial Incision With Dilation in the Endoscopic Treatment of Benign Tracheal Stenosis: A Systematic Review. J Bronchology Interv Pulmonol. 2026 Feb 20;33(2):e01064. doi: 10.1097/LBR.0000000000001064. eCollection 2026 Apr 1.
PubMed 41718210
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Transcriptomic Profile Changes Following Carbon Dioxide (CO2) Laser Wedge Resection Versus Radial Incision for Benign Tracheal Stenosis
- ClinicalTrials.gov ID
- NCT07463742
- Acronym / sponsor ID
- HP-00112650
- Conditions
- Tracheal Stenosis
- Keywords
- tracheal stenosis, bronchoscopy, wedge resection, CO2 laser
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2031 (estimated)
- Study completion
- 1 May 2032 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some people develop a narrowing of their windpipe (trachea), called benign tracheal stenosis, which can make it hard to breathe. Doctors often treat this by using a bronchoscope-a thin, flexible tube with a camera-to open up the airway or remove scar tissue. While these procedures help patients breathe better, we do not fully understand why the narrowing occurs or how the tissue heals afterward.
The purpose of this study is to better understand the biological changes in the airway tissue before and after these standard medical procedures. During the procedure, small samples of tissue that would already be collected as part of normal care will be analyzed in the laboratory. The results may help doctors learn more about airway healing and could guide better treatments in the future.
Detailed description
Benign tracheal stenosis (BTS) is an uncommon but potentially life-threatening condition caused by fibroinflammatory scarring that narrows the airway. Etiologies include post-intubation, tracheostomy, and idiopathic disease. Bronchoscopic intervention is the first-line treatment; however, recurrence rates exceed 50%, and the optimal technique remains uncertain. Two widely used modalities-carbon dioxide (CO₂) laser wedge resection and radial incision with dilation-have never been directly compared in a randomized trial. Preliminary evidence, including our meta-analysis, suggests wedge resection may yield lower recurrence rates and longer recurrence-free intervals, but the biological mechanisms underlying these differences remain unknown.
This project will conduct a randomized pilot study of 40 BTS patients comparing CO₂ laser wedge resection and radial incision with dilation. Endobronchial biopsies will be collected before and one month after intervention and analyzed using bulk ribonucleic acid (RNA) sequencing and spatial transcriptomics to capture both global and spatially resolved gene expression changes. This dual-modality approach will map molecular pathways involved in fibrosis resolution, immune cell dynamics, and epithelial repair. Patients will be followed for two years with standardized clinical, physiologic, and imaging assessments, and molecular signatures will be correlated with recurrence-free survival and other clinically meaningful outcomes.
By combining prospective clinical data with high-resolution transcriptomic profiling, this study addresses critical gaps in mechanistic understanding and comparative effectiveness evidence for BTS management. The findings will establish a biologic framework for selecting optimal bronchoscopic approaches, identify candidate therapeutic targets to prevent recurrence, and generate effect-size estimates to power a future multicenter randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. Carbon dioxide (CO2) laser wedge resection; 2. Radial incision and dilation
| Arm | Type | Receives |
|---|---|---|
| Carbon dioxide (CO2) laser wedge resection | Experimental | Procedure: Bronchoscopy, carbon dioxide (CO2) laser wedge resection |
| Radial incision and dilation | Active comparator | Procedure: Radial incision with dilation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- symptomatic tracheal stenosis
- idiopathic subglottic stenosis
- iatrogenic tracheal stenosis from intubation or tracheostomy
Key exclusion criteria (7 listed)
- positive ANA or ANCA
- tracheal stenosis from infection, i.e. TB
- tracheal stenosis with cartilage fracture
- tracheal stenosis with malacia
- tracheal stenosis from malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscopy, carbon dioxide (CO2) laser wedge resectionCO2 laser wedge resection - removing scar tissue with laser, leading tissue bridges. | Procedure or surgery | Carbon dioxide (CO2) laser wedge resection |
| Radial incision with dilationRadial incision with dilation - making radial cuts at the circumferential scar site, followed by balloon dilation. | Procedure or surgery | Radial incision and dilation |
Primary outcome
Change in transcriptomic pathway activation scores
Time frame: at the time of the second procedure (1 month from the initial invervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 41718210Kang N, Ho A, Bain PA, Zhang C. Comparing CO2 Laser Wedge Resection to Radial Incision With Dilation in the Endoscopic Treatment of Benign Tracheal Stenosis: A Systematic Review. J Bronchology Interv Pulmonol. 2026 Feb 20;33(2):e01064. doi: 10.1097/LBR.0000000000001064. eCollection 2026 Apr 1.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) from this study will be shared in a de-identified form for research purposes only, consistent with participant confidentiality protections. The shared dataset will include: Clinical data: age, sex, relevant medical history related to benign tracheal stenosis, treatment type (CO₂ laser wedge resection vs. radial incision with dilation), recurrence status, symptom scores, spirometry results (PIF, PEF), and imaging findings. Transcriptomic data: bulk RNA-seq and spatial RNA-seq gene expression data from pre- and post-treatment tissue samples, without any personally identifiable information. Exclusions: No names, initials, dates of birth, social security numbers, or other direct identifiers will be shared. All samples and data will be linked only by unique study codes. Intended Use: Shared data will be available to qualified researchers for secondary analyses of benign tracheal stenosis or related molecular research, in accordance with institutional an
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy, carbon dioxide (CO2) laser wedge resection and Radial incision with dilation in people with Tracheal Stenosis, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenchen Zhang, MD (410-328-8138, chenchen.zhang@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in transcriptomic pathway activation scores (time frame: at the time of the second procedure (1 month from the initial invervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07463742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.